What does the FDA Orange Book list for Grafapex and treosulfan (and why it matters for exclusivity)?
The FDA’s Orange Book is the database the public uses to see which drug products are considered eligible for patent protection and/or regulatory exclusivity, and the specific dates tied to those protections. In practice, people searching for “Grafapex treosulfan patents exclusivity” are usually trying to determine two things from the Orange Book: which patents are listed for that specific product and when those protections (and any exclusivities) run out, which can affect when follow-on products may enter the market.
Because your question is specific to “Grafapex treosulfan patents exclusivity,” the key next step is to look up the exact Orange Book entry for the specific active ingredient and product name (the same active ingredient can have different listed products/forms/holders, and exclusivity and patent listings are tied to those entries).
How to find the relevant Orange Book entry (so you get the correct patents and exclusivity end dates)
To get accurate “patents exclusivity” details for Grafapex/treosulfan, the Orange Book search usually needs all of:
- the brand name (e.g., Grafapex) and/or the active ingredient name (treosulfan),
- the dosage form/strength listed for the specific product entry,
- the applicant/holder that matches the product listing.
Once you open the correct entry, the Orange Book will show:
- listed drug product patents (with their expiration dates),
- exclusivity types (where applicable) and their end dates.
What types of exclusivity can appear in the Orange Book, and what they affect
Orange Book “exclusivity” is separate from patents. Patents are property rights about the invention; exclusivity is a regulatory protection that can limit generic or follow-on approvals even if a specific patent situation is different. The Orange Book typically categorizes exclusivity (for example, new chemical entity and other exclusivity frameworks), and each comes with an end date shown in the listing. Those end dates are what matter for “when exclusivity expires.”
How patents and exclusivity interact for market entry
Follow-on products generally look at both:
- patent expiration (and any listed Orange Book patents for the listed drug), and
- exclusivity expiration (the regulatory protection window that can bar approval or limit certain pathways depending on the type of application and the regulatory scheme).
So the practical question many searchers mean is: “When can a company launch a competing product?” Answering that requires reading both the listed patent expiration dates and the listed exclusivity end dates for the specific Orange Book product entry you’re using.
What I need from you to give the exact patent/exclusivity expiration details
I can’t see or quote the Orange Book listing from your message alone. If you paste either of the following, I can extract the exact “patents” and “exclusivity” information and summarize the key dates:
- the Orange Book link for the Grafapex (treosulfan) entry, or
- the Orange Book listing text (patent numbers and expiration dates, and the exclusivity type/end date rows), or
- the applicant/holder name plus dosage form/strength for Grafapex treosulfan.
Quick clarification: are you asking about “Grafapex” as the brand and “treosulfan” as the active ingredient?
If Grafapex is the brand name you’re using, confirm the strength/dosage form (for example, injection strength) because Orange Book entries are product-specific. The patent/exclusivity dates can differ between formulations or different holders of the same active ingredient.
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If you share the Orange Book entry link (or paste the table rows for patents and exclusivity), I’ll reply with the specific patent numbers, their expiration dates, the exclusivity type(s), and the exclusivity end date for Grafapex/treosulfan.